Evaluation of the Effect and Side Effect Profile of Covid-19 Vaccine in Cancer Patients

Sponsor

Bezmialem Vakif University (Other)

Overall Status

Completed

CT.gov ID

NCT04771559

Collaborator

(none)

1,500

Enrollment

Locations

Arms

Actual Duration (Months)

300

Patients Per Site

74.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to evaluate the effects and side effects of inactive COVID-19 vaccine in patients with cancer and compare them with the healthy control group.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Cancer	Other: COVID-19 antibody test	N/A

Detailed Description

The aim of the study is to evaluate the effects and side effects of inactive COVID-19 vaccine in patients with cancer. Patients followed up in medical oncology clinic and healthy volunteers will be enrolled in the study. Blood samples of participants will be taken 4 weeks after the second dose of the COVID-19 vaccine. After blood samples are centrifuged at 2500 rpm for 10 minutes, the separated serum will be backed up in two different eppendorf tubes and stored at -80 or -20 degrees. The samples will be delivered to the working center in a manner suitable for cold chain transport. COVID-19 antibody test will be performed on the blood samples. In addition, volunteers will be questioned in terms of side effects that may develop after vaccination and the information obtained will be recorded in the database together with the clinical data of the patients.

Study Design

Study Type:

Interventional

Actual Enrollment :

1500 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study consists of two groups : 1) Cancer patients, 2) Healthy controls Blood samples will be taken from the participants of the two groups 4 weeks after the second dose of the COVID-19 vaccine and antibody testing will be performed. Additionally participants will be questioned for side effects of the vaccine and the data will be registered.The study consists of two groups : 1) Cancer patients, 2) Healthy controls Blood samples will be taken from the participants of the two groups 4 weeks after the second dose of the COVID-19 vaccine and antibody testing will be performed. Additionally participants will be questioned for side effects of the vaccine and the data will be registered.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Evaluation of the Effect and Side Effect Profile of Covid-19 Vaccine in Cancer Patients

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Jun 1, 2021

Actual Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Cancer patients Covid-19 antibody levels of patients will be measured	Other: COVID-19 antibody test 5 cc blood sample from each participant will be taken 4 weeks after the second dose of the COVID-19 vaccine . After blood samples are centrifuged at 2500 rpm for 10 minutes, the separated serum will be backed up in two different ependorphs and stored at -80 or -20 degrees. The samples will be delivered to the working center in a manner suitable for cold chain transport. COVID-19 antibody test will be performed on the blood samples
Other: Healthy control Covid-19 antibody levels of healthy controls will be measured	Other: COVID-19 antibody test 5 cc blood sample from each participant will be taken 4 weeks after the second dose of the COVID-19 vaccine . After blood samples are centrifuged at 2500 rpm for 10 minutes, the separated serum will be backed up in two different ependorphs and stored at -80 or -20 degrees. The samples will be delivered to the working center in a manner suitable for cold chain transport. COVID-19 antibody test will be performed on the blood samples

Arm

Intervention/Treatment

Other: Cancer patients

Covid-19 antibody levels of patients will be measured

Other: COVID-19 antibody test

5 cc blood sample from each participant will be taken 4 weeks after the second dose of the COVID-19 vaccine . After blood samples are centrifuged at 2500 rpm for 10 minutes, the separated serum will be backed up in two different ependorphs and stored at -80 or -20 degrees. The samples will be delivered to the working center in a manner suitable for cold chain transport. COVID-19 antibody test will be performed on the blood samples

Other: Healthy control

Covid-19 antibody levels of healthy controls will be measured

Other: COVID-19 antibody test

Outcome Measures

Primary Outcome Measures

Antibody levels [1 month]
COVID-19 antibody titers of the patients will be measured in blood samples.

Secondary Outcome Measures

Side effects [1 month]
Participants will be questioned for common side effects

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

For the patient group :

Patients with pathological and clinical cancer diagnosis
Older than 18 years
Patients two doses of COVID-19 vaccine administered
Volunteering to participate in the study

For the control group :

No known cancer diagnosis or history
Older than 18 years
Two doses of COVID-19 vaccine administered
Volunteering to participate in the study -

Exclusion Criteria:

Not volunteering to participate in the study
< 18 years
Not administered two doses of the COVID-19 vaccine
Covid-19 infection history -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bezmialem University	Istanbul	Fatih	Turkey	34090
2	Okmeydani Research Hospital	Istanbul	Fatih	Turkey
3	Acibadem University	Istanbul		Turkey
4	Medeniyet University	Istanbul		Turkey
5	Medipol University	Istanbul		Turkey

Sponsors and Collaborators

Bezmialem Vakif University

Investigators

Study Chair: MAHMUT GUMUS, PROF, MEDENIYET UNIVERSITY
Study Chair: AHMET BILICI, PROF, Medipol University
Study Chair: HACI MEHMET TURK, PROF, BEZMIALEM UNIVERSITY
Study Director: MESUT SEKER, PROF, BEZMIALEM UNIVERSITY
Principal Investigator: AYSE IREM YASIN, MD, BEZMIALEM UNIVERSITY
Study Chair: BILGE SUMBUL, ASOC.PROF., BEZMIALEM UNIVERSITY
Study Chair: FAYSAL DANE, PROF, Acibadem University
Study Chair: CAGLAYAN GEREDELI, ASOC.PROF., OKMEYDANI RESEARCH HOSPITAL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ayşe İrem Yasin, MD, Bezmialem Vakif University

ClinicalTrials.gov Identifier:

NCT04771559

Other Study ID Numbers:

132620

First Posted:

Feb 25, 2021

Last Update Posted:

Aug 3, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ayşe İrem Yasin, MD, Bezmialem Vakif University

Cancer, Covid-19, Vaccine

Additional relevant MeSH terms:

COVID-19

Antibodies

Study Results

No Results Posted as of Aug 3, 2021